BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMYLASE REAGENT SET (MODIFIED CARAWAY)

    K Number: K860530 · Decision Feb 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    41
    Review Days
    16

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    Basic Information

    Device Name
    AMYLASE REAGENT SET (MODIFIED CARAWAY)
    K Number
    K860530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sterling Diagnostics, Inc.
    Date Received
    February 12, 1986
    Decision Date
    February 28, 1986
    Product Code
    CJA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CJA Amyloclastic, Amylase

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